(252 days)
The Adam Spence Percutaneous Catheter Introducer is intended to provide a means for percutaneous vascular access while minimizing the back flow of blood during the introduction of cardiovascular devices such as catheters and guide wires.
The Adam Spence Corp. Percutaneous Catheter Introducer (PCI) is a disposable device intended for use in diagnostic angiographic procedures.
Here's an analysis of the provided text regarding the Adam Spence Percutaneous Catheter Introducer, focusing on acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Feature/Test) | Reported Device Performance (Adam Spence PCI) | Predicate Device Performance (Daig Fast-Cath™) | Acceptance Threshold/Standard (Implied/Explicit) |
|---|---|---|---|
| Tensile Properties | Exceeds Requirement | Exceeds Requirement | Manufacturer's internal requirement (not specified quantitatively) |
| Valve/Sheath Leak | No Leakage | 4 Fr. leaked after dilation | No leakage |
| Insertion/Withdrawal | Substantially Equivalent to Predicate | Acceptable | Performance comparable to predicate device |
| Air Aspiration | Greatly Exceeded Predicate Device | Acceptable | Greater or equivalent to predicate device |
| Tip Peelback | No Damage or Peelback; Lower average insertion force required to puncture skin than predicate device. | No Damage or Peelback; Higher average insertion force required to puncture skin than ASC PCI. | No damage/peelback; Insertion force comparable to or better than predicate. |
| Sterile Packaging | Sterile and Bulk Packaged | Sterile Pack | Sterile |
| Sterilization Method | Ethylene Oxide Gas | Ethylene Oxide Gas | Ethylene Oxide Gas |
| Shelf Life | 3 Years | 3 Years | 3 Years |
| Available Sizes | 4 though 9 French size | 4 through 9 French size | 4 though 9 French size |
| Biocompatibility | All appropriate biocompatibility tests have been performed per ISO 10993 | (Not directly stated for predicate) | ISO 10993 compliance |
Notes on Acceptance Criteria:
- Many acceptance criteria are comparative against a predicate device rather than absolute quantitative standards.
- The document explicitly states that "Performance standards have not been established under Section 514 of the Food, Drug and Cosmetic Act."
- Referenced standards like "ANSI MD70.1-1983" and "ISO/DIS 11070.2" likely define specific physical and performance requirements that the tests above would then demonstrate compliance with, but the specific numerical thresholds from these standards are not detailed in the provided text.
2. Sample Sizes and Data Provenance
The provided document describes a summary of technological characteristics and performance testing for the Adam Spence Percutaneous Catheter Introducer compared to a predicate device. However, it does not provide specific details on the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). The testing appears to be primarily bench testing (laboratory-based) comparing physical properties and performance aspects rather than clinical trials with patient data.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for a test set. The evaluation is based on engineering and performance testing.
4. Adjudication Method
No adjudication method is mentioned, as the evaluation is based on objective performance testing rather than expert-based assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The device is a physical medical device (catheter introducer), not an imaging or diagnostic AI tool that would typically involve human readers.
6. Standalone Performance Study
Yes, a standalone performance evaluation was done for the Adam Spence PCI. The "Summary of Technological Characteristics" table presents the performance of the Adam Spence PCI (algorithm/device only) in various tests (e.g., tensile properties, valve/sheath leak, air aspiration, tip peelback) independent of human-in-the-loop performance, though often in direct comparison to the predicate device.
7. Type of Ground Truth Used
The "ground truth" for the performance claims appears to be established through engineering measurements, physical testing, and laboratory experiments (e.g., measuring tensile strength, observing leakage, quantifying insertion force). For biocompatibility, it's compliance with established ISO standards.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here as the device is a physical medical device, not an AI/machine learning algorithm.
9. How Ground Truth for the Training Set Was Established
Not applicable for a physical medical device as there is no "training set" in the machine learning sense. The device's design and manufacturing are based on established engineering principles and materials science, with performance validated through direct testing against predetermined specifications or predicate device performance.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).